Registration Dossier
Registration Dossier
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EC number: 247-466-3 | CAS number: 26116-12-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: 2a: Guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Sensitizers induce primary proliferation of lymphocytes in the lymph node draining the application site. The Local Lymph Node Assay (LLNA) assesses this proliferation. The lymphocyte subpopulations of the draining lymph nodes are studied by flow cytometry.
Evaluation is based on the ratio between T-cells and B-cells (CD3:CD19). This ratio is an indicator of the B cell proliferation induced by the treatment of mice with contact allergens. If the ratio of T cells to B cells is below 4, the test article is considered as a sensitizer. - GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1-ethylpyrrolidin-2-ylmethylamine
- EC Number:
- 247-466-3
- EC Name:
- 1-ethylpyrrolidin-2-ylmethylamine
- Cas Number:
- 26116-12-1
- Molecular formula:
- C7H16N2
- IUPAC Name:
- 1-ethylpyrrolidin-2-ylmethylamine
- Details on test material:
- Test article name: PE0851 [(1-ethyl 2-pyrrolidinyl) methanamine], an intermediate product of Amisulpride synthesis.
Test article batch no.: BS00001
Certificate of analysis: Purity: > 99%
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: Balb/c N
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 5 % (in 25 µL)
- No. of animals per dose:
- 4
- Details on study design:
- Treatment: 25 µl to the dorsum of both ears on day 1, 2 and 3.
- Positive control substance(s):
- other: DNCB (Dinitrochlorobenzene) 0.5%
Results and discussion
- Positive control results:
- R = CD3/CD19 = 2.6
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 1-ethylpyrrolidin-2-ylmethylamine: Ratio CD3/CD19 = 5.4 Blank control=vehicule: Ratio CD3/CD19 = 8.6
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Not applicable
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In the experimental conditions, PE0851 (batch BS00001) is not a sensitizer.
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